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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Free Thyroxine
510(k) Number K823005
Device Name BIO MAG FREE T4 RADIOIMMUNOASSAY KIT
Applicant
BIOCLINICAL GROUP
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIOCLINICAL GROUP
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1695
Classification Product Code
CEC  
Date Received10/12/1982
Decision Date 12/15/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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